8/22/2014
15
Determination of Total CS SMPR
Screening Method for Adulterants in CS SMPR
Parameter
Parameter
Requirements
Target Test
Concentration (w/w)
Minimum Acceptable
Results
Minimum of 33
replicates presenting all
target compounds in
Annex I and all matrix
types listed in Annex II
≤ 5%
Single laboratory validation
Matrix
Studies
(1)
,
spiked at or below the
designated low level
target test
concentration
90% POD
(1)
of the
pooled data for all
target compounds and
matrices.
High concentration.
Minimum of 5
replicates per matrix
type spiked at the
designated high level
target test
concentration.
ca. 20%
100% correct analyses
are expected per
matrix type
(2)
Zero concentration.
Minimum of 5
replicates per matrix
type that have tested
0 %
negative with a second
method and have not
been spiked.
Multi‐
laboratory
study
LPOD
Use Appendix N: ISPAM
Guidelines for
Validationof
Qualitative Binary
Chemistry Methods
≤ 5%
≥ 0.85
ca. 20%
≥ 0.95
LPOD
(0)
0 %
≤ 0.05
Notes:
(1)
95%confidence interval
(2)100%correctanalyses areexpected. Some aberrations may be acceptable if the aberrations are investigated, andacceptable explanations
canbe determined and communicated tomethod users(3) LPODandLPOD
(0)
arenot required for First Action Official Methods ofAnalysis
approval.
